Therapist-guided Internet Treatment for Hazardous and Harmful Alcohol Use. A Feasibility Study

NCT ID: NCT04544930

Last Updated: 2022-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-15
• Study Completion Date: 2021-11-30

Brief Summary

The aim of the present study is to test the feasibility of therapist-guided Internet treatment for hazardous (risky) and harmful alcohol use among adults 18 years and older. The hypothesis is that the intervention is feasible and that it can help people change risky drinking habits at an early stage before developing into problems that are more serious.The therapist-guided Internet treatment addresses the person's need for confidentiality and contributes to reducing the stigma associated with visiting a substance abuse clinic.

Detailed Description

Background:

A significant proportion of people with substance abuse do not seek help for their problems and therefore do not receive the necessary help at an early stage. An important reason for this is the stigma associated with substance abuse. Therapist-guided Internet treatment has been developed and tested in recent years as an approach that increases access to effective treatment for a variety of mental and substance-related problems and disorders. Internet-based interventions increase the patient's choice of type of treatment and give the patient an experience of having control over their own behavior change. Moreover, such treatment is independent of where you live, and you do not need to attend a clinic. In addition, by offering therapist-guided Internet treatment, therapists can treat far more patients compared to regular face-to-face treatment. In this way, the health services, which are already under severe pressure due to many new and competing tasks, are relieved.

Research questions:

1. Is therapist-guided Internet treatment for hazardous and harmful alcohol use feasible for self-referred persons?

2. What factors contribute/do not contribute to the feasibility of treatment?

3. Can the intervention help people change risky drinking habits before it develops into problems that are more serious?

4. How do participants experience the intervention?

Methods:

Participants:

A total of 30 participants will be recruited through announcements in social media, newspapers and through GP's and other health care services. Participants will be recruited from the catchment area of Haukeland University Hospital, Western Norway, and Vestfold Hospital, Eastern Norway.

Design:

The study will be conducted as an open, 6-months follow-up study, to assess whether the design is suitable for a randomized controlled trial in the next round. Both quantitative and qualitative methods will be used to investigate the feasibility of the treatment program.

Data collection:

Assessments will be carried out at start of treatment (T1), through the treatment course (T2) and at the end of treatment (T3) and at follow-up (T4). Qualitative interviews will be conducted at the end of treatment.

Intervention:

The treatment program is developed at Vestfold Hospital, Norway. It is based on Internet- based cognitive behavior therapy (ICBT). The treatment program consists of eight text-based self-help modules on the Internet that participants can access via secure login using Bank identification (ID) (security level 4). The self-help modules include psychoeducation, tasks and exercises. The therapist guidance is secondary to the self-help modules. The therapist provides feedback to the patient online in the secured program once a week.

Statistics:

Sample size:

Since this is a feasibility study primarily intended to test the feasibility of therapist-guided Internet treatment for hazardous and harmful alcohol use, the sample will be limited to 30 participants. Therefore, power analysis is not performed.

Statistical methods:

Both statistical and interpretative methods will be used. Descriptive statistics (percentages, means, standard deviations), as well as statistical and clinical change. Qualitative in-depth interviews will be analyzed using thematic content analysis.

Plan for activities and dissemination:

Scheduled start of data collection is September 2020. The data collection will continue until the summer of 2021. The follow-up period will be completed by the end of 2021.

The results of the feasibility study will be published in peer-reviewed journals. Furthermore, the results will be disseminated to the public through media (including social media), and as information aimed at both health and social care professionals, patient groups and user forums.

Conditions

Alcohol Abuse; Internet-Based Intervention

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

therapist-guided

Therapist-guided Internet treatment based on cognitive behavior therapy (ICBT).

Group Type: EXPERIMENTAL

therapist-guided

Intervention Type: BEHAVIORAL

Therapist-guided Internet treatment comprises eight text modules on the Internet that include psychoeducation, tasks and exercises. Key elements are setting goals for treatment, identifying and challenging negative automatic thoughts through a number of exercises and behavioral experiments, as well as making a plan for relapse prevention. Therapist guidance is secondary to the self-help modules, and the therapist provides feedback to the patient online in the secured program once a week

Interventions

therapist-guided

Therapist-guided Internet treatment comprises eight text modules on the Internet that include psychoeducation, tasks and exercises. Key elements are setting goals for treatment, identifying and challenging negative automatic thoughts through a number of exercises and behavioral experiments, as well as making a plan for relapse prevention. Therapist guidance is secondary to the self-help modules, and the therapist provides feedback to the patient online in the secured program once a week

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18 years or older
• access to the Internet
• interested in receiving Internet treatment for changing drinking habits
• a score of 6 or higher for women and 8 or higher for men on the Alcohol Use Disorder Identification Test (AUDIT)

Exclusion Criteria

• diagnosed alcohol dependence or addiction to other drugs and already in treatment
• serious reading and/or writing difficulties
• cognitive impairment/dementia
• severe mental disorder or in need of other treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Else Marie Løberg, PhD

Role: STUDY_DIRECTOR

Haukeland University Hospital

Locations

Haukeland University Hospital

Bergen, , Norway

Vestfold Hospital

Tønsberg, , Norway

Countries

Norway

Other Identifiers

31352

Identifier Type: -

Identifier Source: org_study_id